A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

July 31, 2012

Conditions
Hemophilia B
Interventions
BIOLOGICAL

Recombinant Coagulation Factor IX Albumin Fusion Protein

Study subjects will receive a single dose of 25IU/kg of rIX\_FP for pharmacokinetic analysis. Subjects will then be treated for approximately 5 months. The treatment dose will be based on the subject's PK profile and the subject's bleeding phenotype.

Trial Locations (2)

Unknown

Study Site, Sofia

Study Site, Tel Aviv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY